Novel HER2-Targeting Antibody-Drug Conjugate Shows Broad Antitumor Activity

Excerpt:

“A novel HER2-targeting antibody-drug conjugate showed promising antitumor activity across multiple tumor types, including HER2-postive breast cancer, according to phase I data presented at the 2016 ESMO Congress.

” ‘Antibody-drug conjugates represent promising drugs with a wider therapeutic window by effecting efficient and specific drug delivery to oncogene expressing tumor cells,’ explained lead author Kenji Tamura, MD, PhD, chairman, Department of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.”

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Investigational Immunotherapy Was Safe, Tolerable, and Showed Some Activity Against Melanoma

Excerpt:

“The investigational immunotherapeutic IMC-20D7S was safe, well tolerated, and showed signs of modest clinical activity for patients with advanced melanoma, according to results from a first-in-human phase I clinical trial published in Clinical Cancer Research, a journal of the American Association for Cancer Research.

” ‘Even though immunotherapy has significantly improved outcomes for some patients with advanced melanoma, many patients have tumors that do not respond to currently available treatments or have tumors that initially respond but then become resistant to them,’ said Jedd D. Wolchok, MD, PhD, the Lloyd J. Old/Virginia and Daniel K. Ludwig Chair in Clinical Investigation and chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center (MSK) in New York. ‘In this study, we evaluated the safety and early clinical activity of a new antimelanoma immunotherapy.’ ”

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Tagrisso (Osimertinib) Shows Clinical Activity in Patients with Leptomeningeal Disease from Lung Cancer

Excerpt:

“AstraZeneca today announced clinical and safety data for osimertinib in patients with leptomeningeal (LM) disease, a complication of epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC),1 where cancer cells spread to the cerebrospinal fluid (CSF). LM is a devastating disease often associated with advanced lung cancer.

“The updated BLOOM Phase I trial results, presented at the American Society of Clinical Oncology (ASCO) annual meeting, showed that irrespective of T790M mutation status of patients, osimertinib demonstrated activity through assessments with MRI imaging intracranial response.”

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Pfizer Presents Promising Data from Next Generation ALK/ROS1 Inhibitor in Advanced Non-Small Cell Lung Cancer

Excerpt:

“Pfizer Inc. (NYSE:PFE) today announced encouraging new data from a Phase 1/2 study of lorlatinib, the proposed generic name for PF-06463922, Pfizer’s investigational, next-generation ALK/ROS1 tyrosine kinase inhibitor. The study showed clinical response in patients with ALK-positive or ROS1-positive advanced non-small cell lung cancer (NSCLC), including patients with brain metastases. These data were presented today in an oral presentation at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“The results presented are from the dose escalation component of an ongoing Phase 1 study of patients with ALK-positive or ROS1-positive NSCLC, with or without brain metastases, who were treatment-naïve or had disease progression after at least one prior tyrosine kinase inhibitor (TKI). Among patients with ALK-positive metastatic NSCLC, the overall response rate (ORR) with lorlatinib was 46 percent, with three patients achieving complete responses and 16 patients achieving a partial response (95% CI: 31-63). The median progression free survival (PFS) was 11.4 months (95% CI: 3.4 – 16.6). The majority of patients had received two or more prior ALK TKIs. Additionally, lorlatinib showed the ability to decrease the size of brain metastases in patients with ALK-positive or ROS1-positive metastatic NSCLC.”

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Investigational CDK4/6 Inhibitor Abemaciclib is Active Against a Range of Cancer Types

Excerpt:

“The investigational anticancer therapeutic abemaciclib, which targets CDK4 and CDK6, showed durable clinical activity when given as continuous single-agent therapy to patients with a variety of cancer types, including breast cancer, non–small cell lung cancer (NSCLC), glioblastoma, and melanoma, according to results from a phase I clinical trial published in Cancer Discovery, a journal of the American Association for Cancer Research.

“The results of the trial supported the U.S. Food and Drug Administration (FDA) decision to grant breakthrough therapy designation to abemaciclib (previously known as LY2835219) for patients with refractory hormone receptor–positive advanced or metastatic breast cancer, according to one of the senior authors of the study, Amita Patnaik, MD, associate director of clinical research at South Texas Accelerated Research Therapeutics in San Antonio, Texas.”

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Ignyta Announces Updated Data from Entrectinib Phase 1 Clinical Trials at the 2016 AACR Annual Meeting

Excerpt:

“Ignyta, Inc. (RXDX),a precision oncology biotechnology company, today announced that updated results of its Phase 1 clinical trials of entrectinib, the company’s proprietary oral tyrosine kinase inhibitor targeting solid tumors harboring activating alterations to NTRK1, NTRK2, NTRK3, ROS1 or ALK, were presented in an oral plenary session at the 2016 Annual Meeting of the American Association for Cancer Research (AACR) in New Orleans, Louisiana.

“ ‘We continue to be excited by entrectinib’s ability to help patients with advanced cancer,’ said Jonathan Lim, M.D., Chairman and CEO of Ignyta. ‘With respect to efficacy, in the 25 patients in the Phase 1 trials who would meet the eligibility criteria for our Phase 2 clinical trial, we saw tumor regression in 20 patients, or 80%. Nineteen out of 24 patients with extracranial solid tumors had a confirmed RECIST response, representing a 79% overall response rate; and one patient with an astrocytoma had evidence of substantial tumor regression by volumetric measurement. These responses were observed in patients with each of NTRK, ROS1 and ALK rearrangements, and across six tumor histologies, including complete and/or durable responses in both primary and metastatic tumors of the central nervous system.’ ”

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New RAF-targeted Therapeutic Shows Early Promise Against Tumors With BRAF and RAS Mutations

Excerpt:

“The new investigational anticancer therapeutic BGB-283, which targets the RAF family of proteins, was safe, tolerable, and showed signs of clinical activity in patients who had a range of types of cancer with mutations in BRAF, KRAS, and NRAS, according to results from a phase I clinical trial presented here at the AACR Annual Meeting 2016, April 16-20.

“ ‘BRAF gene mutations fuel cancer cell proliferation and survival in a number of types of cancer, including melanoma, and thyroid and colorectal cancers,’ said Jayesh Desai, FRACP, a medical oncologist at The Royal Melbourne Hospital in Melbourne, Australia. ‘In melanoma, the BRAF V600E mutation predominates, and specific inhibitors of the BRAF V600E mutant protein have been approved for treating patients with melanoma with BRAF V600E gene mutations.’ ”

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Pexidartinib Plus Pembrolizumab Combo Tested in Ovarian and Other Solid Tumors

Excerpt:

“An ongoing clinical trial has begun the process of evaluating whether the addition of a booster agent can take the anticancer activity of PD-1 directed immunotherapy to another level.

“Investigators in a multicenter trial are evaluating the impact of pexidartinib (PLX3397)—an inhibitor of colony stimulating factor 1 (CSF1)—on the activity of the PD-1 signaling inhibitor pembrolizumab (Keytruda) in various types of solid tumors.

“The two-part phase 1/2 trial will establish a recommended dose for pexidartinib to use in combination with standard pembrolizumab dosing and then evaluate the combination in 500 patients representing 12 types of cancer.”

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Phase 1 Results Point to Larger Trial of Enzalutamide and Fulvestrant in Breast Cancer

“Results of a multicenter phase 1 clinical trial presented today at the 2015 San Antonio Breast Cancer Symposium show that the anti-androgen agent enzalutamide is active and well-tolerated alone and with fulvestrant in patients with advanced breast cancer. The study takes another important step toward larger clinical trials targeting androgen receptors in breast cancer.

” ‘We’ve known for years that prostate cancer is driven by androgens and now it’s increasingly clear that androgens and androgen receptors can influence many breast cancers as well. AR is actually even more prevalent in breast cancer than estrogen or progesterone receptors. Targeting androgen receptors in breast cancer gives us a new way to attack the disease,’ says Jennifer Richer, PhD, investigator at the University of Colorado Cancer Center. Results represent collaboration with CU Cancer Center clinical collaborator Anthony Elias, MD, Memorial Sloan Kettering, Medivation, Inc. and Astellas Pharma Global Development.”